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RECOMMENDATION FOR DUE DILIGENCE WHEN PURCHASING AN AUTOMATIC EXTERNAL DEFIBRILLATOR (AED)

Date: 5/1/2009

Thanks to Tom Daly (dalyconsulting@yahoo.com) for the suggestion we exercise due diligence when purchasing AEDs. An April 2009 recall of AEDs supports such a policy.

Medical Device Recall: ZOLL AED Plus Defibrillator

The U.S. Food and Drug Administration is reporting the following medical device recall:

Product: ZOLL AED Plus Defibrillator. This product was manufactured from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009.

Use: This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient's heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

Reason for Recall: The AED failed to deliver the defibrillation energy.

Read the Complete Recall

Prior AED recall data is covered in the additional FDA website link: http://www.fda.gov/cdrh/recalls/recall-082407.html "

The basis for recalls has included:

 Voice prompt failure,

 Unexpected shutdown,

 Inappropriate shock or appropriate shock not delivered,

 Low energy shock,

 Blown fuse.